Study on Quantitative Detection of Bacterial Endotoxins in Methylthioninium Chloride Injection / 中国药房

OBJECTIVE:To establish a method for detecting bacterial endotoxins in methylthioninium chloride injection (MCI) quantitatively. METHODS: Kinetic turbidimetric limulus test was applied to detect bacterial endotoxins in MCI quantitatively, and compared with gel-clot method. RESULTS: MCI was un-interfered with the test for bacterial endotoxins at the concentration of 0.125 mg?mL-1; the content of bacterial endotoxins in all samples tested (10 mg?mL-1) were not more than 0.25 EU?mg -1, which were in accordance with the result of gel-clot method. CONCLUSIONS: Kinetic turbidimetric limulus test provides a new way to detect bacterial endotoxins in MCI quantitatively.